NPRA Special Access Scheme – Malaysia

NPRA SAS FormControl of Drugs and Cosmetics Regulations 198414 days

Description & Eligibility

Malaysia's National Pharmaceutical Regulatory Agency Special Access Scheme allowing access to unregistered medicines for patients with serious or life-threatening conditions.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

Malaysian Drug Control Authority Act 1984

Countries Using This Pathway (1)

NPRA Special Access Scheme – Malaysia
Approval FormNPRA SAS Form
Timeline14 days
Legal StatusControl of Drugs and Cosmetics Regulations 1984
Source Ref.Malaysian Drug Control Authority Act 1984
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified
NPRA Special Access Scheme – Malaysia — Regulatory Pathway | OrphanDrug